US20240293614A1 - Agent administering medical device - Google Patents
Agent administering medical device Download PDFInfo
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- US20240293614A1 US20240293614A1 US18/586,812 US202418586812A US2024293614A1 US 20240293614 A1 US20240293614 A1 US 20240293614A1 US 202418586812 A US202418586812 A US 202418586812A US 2024293614 A1 US2024293614 A1 US 2024293614A1
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- endoscope
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- barrier
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/155—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by gas introduced into the reservoir
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- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
- A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
- A61M11/007—Syringe-type or piston-type sprayers or atomisers
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- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
- A61M11/02—Sprayers or atomisers specially adapted for therapeutic purposes operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised
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- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
- A61M11/06—Sprayers or atomisers specially adapted for therapeutic purposes of the injector type
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
- A61M5/1454—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons spring-actuated, e.g. by a clockwork
-
- A—HUMAN NECESSITIES
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
- A61M5/31586—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle
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- A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/0034—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means adapted to be inserted through a working channel of an endoscope
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- A61B2017/00743—Type of operation; Specification of treatment sites
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- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/02—Gases
- A61M2202/0225—Carbon oxides, e.g. Carbon dioxide
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
- A61M2205/103—General characteristics of the apparatus with powered movement mechanisms rotating
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- A61M2210/00—Anatomical parts of the body
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- A61M2210/00—Anatomical parts of the body
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- A61M2210/1067—Anus
Definitions
- the present disclosure relates generally to a medical device that administers an agent. More particularly, at least some embodiments of the present disclosure relate to a medical device including a system that can be actuated to administer a dosage of an agent to a lumen.
- an endoscopic medical procedure may require hemostasis of bleeding tissue within the gastrointestinal tract, for example in the esophagus, stomach, or intestines.
- a user inserts a sheath of an endoscope into a body lumen of a patient.
- the user utilizes a handle of the endoscope to control the endoscope during the procedure.
- Tools are passed through a working channel of the endoscope via, for example, a port in the handle, to deliver treatment at the procedure site near a distal end of the endoscope.
- the procedure site is remote from the operator.
- a hemostatic agent may be delivered by a device inserted into the working channel of the endoscope.
- Agent delivery may be achieved through mechanical systems, for example. Such systems, however, may require numerous steps or actuations to achieve delivery, may not achieve a desired rate of agent delivery or a desired dosage of agent, may result in the agent clogging portions of the delivery device, may result in inconsistent dosing of agent, or may not result in the agent reaching the treatment site deep within the GI tract.
- the current disclosure may solve one or more of these issues or other issues in the art.
- a medical device may comprise an enclosure defining a cavity for containing agent, a lumen for receiving a pressurized gas, and a barrier positioned between the cavity and the lumen, the barrier including at least one opening for storing agent, wherein rotation of the barrier relative to the lumen establishes fluid communication between the at least one opening and the lumen for delivering agent from the at least one opening to the lumen.
- a bottom end of the cavity may include a wall adjacent to the barrier, wherein the wall includes a wall opening, wherein the wall opening is located on an area of the wall so that the wall opening is aligned with the at least one opening via rotation of the barrier. Alignment of the wall opening with the at least one opening may permit agent from the enclosure to enter the at least one opening.
- the enclosure may be rotatable relative to the barrier and/or the lumen.
- the barrier may be rotatable relative to the enclosure.
- the agent may remain in the at least one opening until fluid communication between the at least one opening and the lumen is established.
- the enclosure may feed the at least one opening with agent via gravity.
- the at least one opening for storing agent may feed the lumen with agent via gravity when fluid communication between the at least one opening and the lumen is established.
- the at least one opening for storing agent may be a plurality of openings arranged radially about the barrier.
- the plurality of openings may be symmetrically arranged.
- Each of the plurality of openings may be different in size.
- the medical device may further comprise an intermediary barrier, wherein the intermediary barrier is positioned between the barrier and the lumen, and wherein the intermediary barrier includes an intermediary opening positioned to be aligned with one of the plurality of openings via rotation of the barrier.
- the intermediary barrier may be rotatable relative to the barrier.
- the lumen may be a flexible catheter capable of traversing a tortuous body lumen, and further comprising a source of the pressurized gas.
- a medical device may comprise a cartridge including a plurality of chambers, wherein each of the chambers stores a pre-filled amount of agent, a lumen for receiving a pressurized gas, a channel establishing fluid communication between a first end of the cartridge and the lumen for delivering agent from the cartridge to the lumen, and a plunger coupled to a second end of the cartridge so that the plunger is aligned with one chamber of the plurality of chambers, wherein the plunger advances longitudinally into the one chamber, thereby pushing the pre-filled amount of agent towards the channel, and wherein the cartridge is rotatable relative to the plunger to align the plunger with another of the plurality of chambers.
- the plunger may be coupled to the cartridge so that the plunger is spring-biased to a position outside of the one chamber and aligned with the one chamber.
- the medical device may further comprise a trigger including a lever coupled to a linkage via a first articulating joint and a linkage coupled to a plunger via a second articulating joint.
- a method of administering an agent via a medical device may comprise positioning the medical device, including an enclosure, a barrier, and a lumen, so that a distal end of the lumen is adjacent to a targeted site, wherein the barrier is positioned between the enclosure and the lumen, the enclosure containing agent, and the barrier including at least one opening for storing the agent, providing a pressurized gas to the lumen, and rotating the barrier relative to the lumen so that fluid communication is established between the at least one opening and the lumen to deliver the agent from the at least one opening to the lumen.
- the method may further comprise rotating the barrier relative to the lumen so that the at least one opening and the lumen are not in fluid communication after a dose of the agent is delivered from the at least one opening to the lumen.
- FIG. 1 A is a side view of a portion of a shaft of an endoscope including a medical device, according to an embodiment.
- FIGS. 1 B-C are cross-sectional views of the medical device of FIG. 1 A .
- FIG. 2 A is a cross-sectional view of a medical device, according to another embodiment.
- FIG. 2 B is a top view of the barrier of FIG. 2 A .
- FIG. 3 A is a cross-sectional view of a medical device, according to another embodiment.
- FIG. 3 B is a top perspective view of the barrier of FIG. 3 A over the intermediary barrier of FIG. 3 A .
- FIG. 4 A is a side view of a medical device, according to another embodiment.
- FIG. 4 B is a top view of the cartridge of FIG. 4 A .
- distal refers to a portion farthest away from a user when introducing a device into a subject (e.g., patient).
- proximal refers to a portion closest to the user when placing the device into the subject.
- the present disclosure may solve one or more of the limitations in the art.
- the scope of the disclosure is defined by the attached claims and not the ability to solve a specific problem.
- the present disclosure is drawn to medical devices configured to administer doses of agents, e.g., therapeutic agents, among other aspects.
- the agent may be in any suitable form, including a powder form, which may be delivered to a stream of propellant/pressurized gas, e.g., CO 2 , nitrogen, air, etc.
- Said medical devices allow for the administration of agents in metered doses, which allows for a greater consistency in the quantity of the agent that reaches a target site.
- Medical system 5 includes a flexible shaft 50 (e.g., a catheter) and a handle 52 connected at a proximal end of flexible shaft 50 .
- Handle 52 or some other device for actuating or controlling medical system 5 and any tool or devices associated with medical system 5 , includes first and second actuating devices 42 , 43 , which control articulation of flexible shaft 50 , and/or an articulation joint at a distal end of flexible shaft 50 , in multiple directions.
- Devices 42 , 43 may be, for example, rotatable knobs that rotate about their axes to push/pull actuating elements (not shown).
- actuating elements such as cables or wires suitable for medical procedures (e.g., medical grade plastic or metal), extend distally from a proximal end of medical system 5 and connect to flexible shaft 50 to control movement thereof.
- actuating elements may be operated independently of handle 52 .
- Distal ends of actuating elements may extend through flexible shaft 50 and terminate at an actuating joint and/or a distal tip of flexible shaft 50 .
- one or more actuating elements may be connected to an articulation joint, and actuation of actuating elements may control the actuating joint or the distal end of flexible shaft 50 to move in multiple directions.
- one or more electrical cables may extend from the proximal end of endoscope 5 to the distal end of flexible shaft 50 and may provide electrical controls to imaging, lighting, and/or other electrical devices at the distal end of flexible shaft 50 , and may carry imaging signals from the distal end of flexible shaft 50 proximally to be processed and/or displayed on a display.
- Handle 52 may also include ports 54 , 46 for introducing and/or removing tools, fluids, or other materials from the patient. Port 54 may be used to introduce tools. Port 46 may be connected to an umbilicus for introducing fluid, suction, and/or wiring for electronic components. For example, as shown in FIG. 1 A , port 54 receives a tube 100 , which extends from the proximal end to the distal end of flexible shaft 50 , via a working channel 50 a of shaft 50 .
- tube 100 of medical device 1 is attached to a pressurized gas source 56 , e.g., CO 2 , which may be controlled by a user to turn on/off and to adjust a rate at which gas flows into tube 100 .
- a pressurized gas source 56 e.g., CO 2
- Source 56 may be a gas canister or tank, a source of gas supplied by a medical facility, or any other suitable source.
- Medical device 1 further includes an enclosure 10 , and a barrier 11 positioned between enclosure 10 and tube 100 . Enclosure 10 and barrier 11 are coupled to a proximal portion of tube 100 , distal of the connection between tube 100 and source 56 .
- FIGS. 1 B and 1 C illustrate an embodiment of medical device 1 , l′ in FIG. 1 A in further detail.
- medical device 1 includes enclosure 10 defining a cavity for containing an agent 1000 , a tube (e.g., a catheter or a sheath) 100 defining a lumen 100 a receiving pressurized gas, e.g., CO 2 , from a proximal end, and barrier 11 positioned between the cavity of enclosure 10 and lumen 100 a .
- the shape or size of enclosure 10 is not particularly limited, and may be any suitable shape or size, including cylindrical. As indicated by the directional arrows in FIG.
- barrier 11 is rotatable relative to tube 100 and lumen 100 a , e.g., about a central axis of barrier 11 .
- barrier 11 may be rotatable relative to both tube 100 and enclosure 10 .
- enclosure 10 may be rotatable relative to barrier 11 and/or tube 100 . Rotation of barrier 11 may be by any suitable action, for example, by hand or by mechanical, electrical, or pneumatic action.
- Barrier 11 may be an annular, disk-like structure with openings and a passage therethrough.
- barrier 11 includes a first opening 12 a on the barrier surface (e.g., an upper surface) adjacent to the cavity of enclosure 10 , for receiving agent 1000 in a passage 14 that extends through barrier 11 .
- Barrier 11 further includes a second opening 12 b on the opposite barrier surface (e.g., a bottom surface) adjacent to tube 100 and lumen 100 a , from which agent 1000 may be dispensed into lumen 100 a .
- first opening 12 a and second opening 12 b are not particularly limited, and may be any suitable size or shape.
- First opening 12 a and second opening 12 b are located on opposite ends of barrier 11 , but are connected via passage 14 extending across the length and thickness of barrier 11 .
- Tube 100 also includes an opening 101 which may or may not be aligned with second opening 12 b of barrier 11 , depending on the rotational position of barrier 11 relative to tube 100 and lumen 100 a .
- the rotation of barrier 11 relative to tube 100 may establish fluid communication between opening 12 b and lumen 100 a for delivering agent 1000 from passage 14 to lumen 100 a .
- Enclosure 10 feeds opening 12 a with agent 1000 via gravity, and passage 14 storing agent 1000 feeds lumen 100 a with agent 1000 via gravity when second opening 12 b and lumen opening 101 are aligned.
- agent 1000 may be delivered to opening 12 a and/or lumen 100 a via other suitable mechanisms.
- Barrier 11 may also be rotated so that second opening 12 b and opening 101 of lumen 100 a are not aligned, thereby inhibiting the delivery of agent 1000 from passage 14 to lumen 100 a .
- passage 14 receives and stores agent 10000 , until fluid communication between opening 12 b of passage 14 and lumen 100 a is established. It is noted that enclosure 10 , in any rotational position of barrier 11 , is not in fluid communication with lumen 100 a . Furthermore, in embodiments prior to any use, passage 14 may be empty an without agent 1000 .
- a bottom end of the cavity of enclosure 10 may include a wall 105 adjacent to barrier 11 .
- Wall 105 may include an opening 105 a that may or may not be aligned with opening 12 a of barrier 11 , depending on the rotational position of barrier 11 relative to enclosure 10 .
- barrier 11 and/or enclosure 10 may be rotated to align opening 105 a with opening 12 a of barrier 11 to deliver agent 1000 from enclosure 10 to passage 14 through opening 12 a .
- FIG. 1 B shows opening 105 a of wall 105 and opening 12 a of barrier 11 are aligned, thereby feeding passage 14 with agent 1000 from enclosure 10 .
- FIG. 1 C shows barrier 11 rotated by approximately 180° from its position in FIG.
- opening 105 a of wall 105 and opening 12 a are not aligned, being on opposite ends from one another.
- the barrier 11 may be rotatable to any degree for alignment with opening 12 a .
- opening 12 a is sealed by wall 105 , and agent 1000 is no longer fed into opening 12 a .
- opening 105 a aligns with opening 12 a when second opening 12 b does not align with opening 101 of tube 100
- opening 105 a does not align with opening 12 a when second opening 12 b aligns with opening 101 of tube 100 .
- passage 14 may receive agent 1000 , prior to agent 1000 being fed to lumen 100 a .
- a user may then fill enclosure 10 with agent 1000 , if not filled already, and rotate barrier 11 and/or enclosure 10 relative to tube 100 and lumen 100 a so that opening 105 a aligns with opening 12 a , thereby feeding passage 14 with agent 1000 .
- opening 105 a aligns with opening 12 a
- second opening 12 b does not align with opening 101 of tube 100 .
- agent 1000 is received and stored by passage 14 .
- a user may then rotate barrier 11 to align opening 12 b with opening 101 of tube 100 , so that all of agent 1000 stored in passage 14 is fed from passage 14 to lumen 100 a , thereby administering a metered dose of agent 1000 .
- a user may turn on the pressurized gas source at any time prior to the alignment of opening 12 b with opening 101 and supply pressurized gas until the metered dose of agent 1000 reaches the target tissue site.
- a user may start supply of pressurized gas after the supply of agent 1000 to lumen 100 a.
- FIG. 2 A another embodiment of medical device 1 ′ is shown.
- medical device 1 ′ includes an enclosure 10 ′ defining a cavity for containing an agent 1000 , a tube (e.g., a catheter or a sheath) 100 defining a lumen 100 a receiving pressurized gas, e.g., CO 2 , from a proximal end, and a barrier 21 positioned between the cavity of enclosure 10 and lumen 100 a .
- the shape or size of enclosure 10 ′ is also not particularly limited, and may be any suitable shape or size.
- barrier 21 is also rotatable relative to tube 100 and lumen 100 a .
- barrier 21 may be rotatable relative to both tube 100 and enclosure 10 ′.
- enclosure 10 ′ may be rotatable relative to barrier 21 and/or tube 100 . Rotation of barrier 21 and enclosure 10 ′ may also be actuated by any suitable action.
- Barrier 21 includes a plurality of openings, i.e., six openings 22 a - 22 f , of equal or approximately equal size, i.e., width or diameter, symmetrically arranged radially about a central axis of rotation of barrier 21 . It is noted that the number of openings, the size of openings, the shape of openings, and the arrangement of openings on barrier 21 is not particularly limited, and may be any suitable configuration. For example, in other embodiments, barrier 21 may have four circular openings, each of which has varying diameters from one another.
- Each of openings 22 a - 22 f extends through the thickness of barrier 21 , and is configured to receive and store a pre-determined or selected amount of agent 1000 , depending on the size of the openings.
- agent 1000 from enclosure 10 feeds into openings 22 a - 22 f , via gravity in some embodiments, until said openings are filled.
- FIG. 2 A shows half of barrier 21 in perspective to show the position of openings 21 a , 21 b , 21 c , and 21 d.
- an excess amount of agent 1000 above the one opening is shaved off by seal 205 and the one opening is sealed from receiving further agent 1000 from enclosure 10 ′ when that opening aligns with opening 101 of tube 100 .
- This allows for medical device 1 ′ to administer a metered dose, i.e., the amount of agent 1000 stored in openings 22 a - 22 f , per each degree of rotation, e.g., 60°, of barrier 21 and/or enclosure 10 ′.
- barrier 21 may also be rotated so that none of openings 22 a - 22 f are aligned with opening 101 of tube 100 , thereby inhibiting the delivery of agent 1000 from any of openings 22 a - 22 f to lumen 100 a .
- an amount of agent 1000 is stored in openings 22 a - 22 f until fluid communication between the openings and lumen 100 a is established.
- medical device 1 ′ may be delivered into the body of a subject, and directed to an intended target site for agent 1000 administration in the same manner.
- a user may then fill enclosure 10 ′ with agent 1000 , if not filled already, which will fill openings 22 a - 22 f with agent 1000 .
- the user then may rotate barrier 21 relative to tube 100 and lumen 100 a so that one of openings 22 a - 22 f aligns with opening 101 .
- Such alignment results in seal 205 shaving off an excess amount of agent 1000 above the one opening, sealing the one opening from being fed any more of agent 1000 from enclosure 10 ′, and feeding lumen 100 a with agent 1000 stored in the one opening.
- the one opening aligns with opening 101 of tube 100
- the remaining openings 22 a - 22 f do not align with opening 101 of tube 100 .
- agent 1000 is stored within the remaining openings 22 a - 22 f , until each of the remaining openings is aligned with opening 101 via rotation of barrier 21 , in turn.
- a user may turn on the pressurized gas source at any time prior to or during the alignment of one of the openings 22 a - 22 f with opening 101 , as in the embodiment described in connection with FIGS. 1 B- 1 C .
- FIG. 3 A another embodiment of medical device 1 ′′′ is shown.
- Medical device 1 ′′′ is similar to medical device 1 ′, and differences between the two devices will be highlighted.
- Device 1 ′′′ may include any of the features of device 1 ′ and operate in the same or substantially the same way.
- Medical device 1 ′′′ includes an enclosure 10 ′′′, a barrier 41 , and lumen 100 .
- enclosure 10 ′′′ further includes a seal 205 , which is positioned adjacently above barrier 41 , above where one of openings 42 a - 42 c may be located, and directly above opening 101 of tube 100 .
- lumen 100 a of medical device 1 ′′′ receives pressurized gas from a second lumen 102 , which is connected to tube 100 at a point that is proximal to opening 101 .
- medical device 1 ′′′ may receive pressurized gas from a proximal end of lumen 100 a , and may be without second lumen 102 .
- Medical device 1 ′′′ further includes, in at least some embodiments, an intermediary barrier 15 including an opening 16 , positioned between barrier 41 and tube 100 .
- barrier 41 is rotatable relative to intermediary barrier 15 , tube 100 , and lumen 100 a .
- enclosure 10 ′′′ may also be rotatable relative to barrier 41 , intermediary barrier 15 , tube 100 , and lumen 100 a . Rotation of enclosure 10 ′′′ and barrier 41 may be actuated by any suitable action.
- Barrier 41 includes three openings, i.e., 42 a - 42 c , of different sizes, i.e., widths or diameter, arranged radially about a central axis of rotation of barrier 41 , like barrier 21 (referring to FIG. 2 B ).
- a first opening 42 a has the smallest width of the three openings
- a second opening 42 c has the largest width of the three openings
- a third opening 42 b has a width in between that of first opening 42 a and that of second opening 42 c .
- each of openings 42 a - 42 c receives and stores different amounts or doses of agent 1000 .
- enclosure 10 ′′′ and/or barrier 41 may further include markings on their outer surfaces that indicate the locations of openings 42 a - 42 c relative to one another, and to openings 16 and 101 .
- a user may rotate barrier 41 and/or enclosure 10 ′′′, relative to intermediary barrier 15 , tube 100 , and lumen 100 a , to select one of openings 42 a - 42 c based on a desired amount or dose of agent 1000 .
- Intermediary barrier 15 includes opening 16 .
- Opening 16 may be aligned with lumen opening 101 , and also openings 42 a - 42 c , depending on the rotational position of barrier 41 relative to intermediary barrier 15 .
- opening 16 is at least the same width as the largest opening of barrier 41 , i.e., second opening 42 c.
- any one of openings 42 a - 42 c may be aligned with intermediary opening 16 and lumen opening 101 via rotation of barrier 21 .
- Such alignment establishes fluid communication between one of openings 42 a - 42 c and lumen 100 a for delivering agent 1000 from one of openings 42 a - 42 c to lumen 100 a via gravity.
- an excess amount of agent 1000 above the one opening is shaved off by seal 205 and the one opening is sealed from further receiving agent 1000 from enclosure 10 ′′.
- Barrier 41 may also be rotated so that none of openings 42 a - 42 c is aligned with intermediary opening 16 and lumen opening 101 , thereby inhibiting the delivery of agent 1000 from enclosure 10 ′′′ to lumen 100 a .
- varying amounts of agent 1000 are stored in openings 42 a - 42 c until fluid communication between openings 42 a - 42 c and lumen 100 a is established.
- intermediary barrier 15 may also be rotatable relative to enclosure 10 ′′′, barrier 41 , tube 100 , and lumen 100 a , so that opening 16 does not align with any of the openings of barrier 41 , and/or opening 101 as well. This is applicable in embodiments having barriers with multiple openings.
- a user may select another opening 42 a , 42 b , 42 c , etc., via rotation of barrier 41 , that is not adjacent to the currently aligned opening, without having to inadvertently dispense agent 1000 stored in openings adjacent to the currently aligned opening, via the necessary degree of rotation to select other non-adjacent openings.
- medical device 1 ′′′ may be delivered into the body of a subject, and directed to an intended target site for agent 1000 administration in the same manner.
- a user may then fill enclosure 10 ′ with agent 1000 , if not filled already, and rotate barrier 41 relative to intermediary barrier 15 , tube 100 , and lumen 100 a , so that one of openings 42 a - 42 c aligns with openings 16 and 101 .
- Such alignment results in seal 205 shaving off an excess amount of agent 1000 above the one opening, sealing the one opening from being fed any more of agent 1000 from enclosure 10 ′′′, and feeding lumen 100 a with agent 1000 stored in the one opening.
- the one opening aligns with opening 16 of intermediary barrier 15 and opening 101 of tube 100
- the remaining openings 42 a - 42 c do not align with openings 16 and 101 .
- agent 1000 is stored within the remaining openings 42 a - 42 c , until each of the remaining openings is aligned with openings 16 and 101 via rotation of barrier 41 .
- a user may turn on the pressurized gas source at any time prior to or during the alignment of one of the openings 42 a - 42 c with openings 16 and 101 , as in previously described embodiments.
- Medical device 1 ′′ includes a trigger 18 , a rotating cartridge 31 including a plurality of chambers, a lumen 100 receiving pressurized gas from a proximal end, and a channel 14 establishing fluid communication between a distal end of cartridge 31 and lumen 100 for delivering agent 1000 from cartridge 31 to lumen 100 .
- cartridge 31 includes a plurality of symmetrically-arranged chambers, i.e., six chambers 32 a - 32 f , of equal or substantially equal size, each of which stores a pre-filled amount of agent 1000 .
- Trigger 18 includes a lever 18 a coupled to a linkage 18 c via an articulating joint 18 b , and linkage 18 c coupled to a plunger 18 e via another articulating joint 18 d .
- a distal portion of plunger 18 e is housed within a proximal portion of cartridge 31 , and is coupled to cartridge 31 in any suitable manner so that the distal end of plunger 18 e faces one of chambers 32 a - 32 f with which plunger 18 e is aligned.
- a spring 19 coils around a distal portion of plunger 18 e outside of cartridge 31 up until a stop 17 fixated on plunger 18 e , thereby spring-biasing plunger 18 e in its aforementioned position of facing one of chambers 32 a - 32 f .
- Spring 19 is not particularly limited and may be any suitable spring.
- stop 17 may be of any suitable material, such as rubber.
- Trigger 18 is configured so that when lever 18 a is pulled proximally, linkage 18 c likewise pivots proximally relative to plunger 18 e via articulating joint 18 d . Such movements of lever 18 a and linkage 18 c result in plunger 18 e longitudinally advancing towards cartridge 31 and into one of chambers 32 a - 32 f , thereby propelling the pre-filled amount of agent 1000 towards and through channel 14 , which extends downward to tube 100 , thereby feeding agent 1000 to tube 100 via gravity.
- the longitudinal advancement of plunger 18 e may be actuated by any suitable mechanisms, including, but not limited to, mechanical, electrical, or pneumatic mechanisms.
- Plunger 18 e advances within cartridge 31 and one of chambers 32 a - 32 f up until spring 19 is fully compressed, thereby inhibiting any further advancement of plunger 18 e towards cartridge 31 .
- spring-biased plunger 18 e automatically reverts back to its initial position of being outside of and facing one of chambers 32 a - 32 f.
- Cartridge 31 is rotatable relative to plunger 18 e so that any one of chambers 32 a - 32 f is aligned with plunger 18 e .
- cartridge 31 may be configured to rotate or revolve automatically, after one of chambers 32 a - 32 f is emptied by plunger 18 e , so that an adjacent chamber 32 a - 32 f storing a pre-filled amount of agent 1000 is aligned with plunger 18 e.
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Abstract
Description
- This application claims the benefit of priority from U.S. Provisional Application No. 62/942,988, filed on Dec. 3, 2019, which is incorporated by reference herein in its entirety.
- The present disclosure relates generally to a medical device that administers an agent. More particularly, at least some embodiments of the present disclosure relate to a medical device including a system that can be actuated to administer a dosage of an agent to a lumen.
- In certain medical procedures, it may be necessary to stop or minimize bleeding internal to the body. For example, an endoscopic medical procedure may require hemostasis of bleeding tissue within the gastrointestinal tract, for example in the esophagus, stomach, or intestines.
- During an endoscopic procedure, a user inserts a sheath of an endoscope into a body lumen of a patient. The user utilizes a handle of the endoscope to control the endoscope during the procedure. Tools are passed through a working channel of the endoscope via, for example, a port in the handle, to deliver treatment at the procedure site near a distal end of the endoscope. The procedure site is remote from the operator.
- To achieve hemostasis at the remote site, a hemostatic agent may be delivered by a device inserted into the working channel of the endoscope. Agent delivery may be achieved through mechanical systems, for example. Such systems, however, may require numerous steps or actuations to achieve delivery, may not achieve a desired rate of agent delivery or a desired dosage of agent, may result in the agent clogging portions of the delivery device, may result in inconsistent dosing of agent, or may not result in the agent reaching the treatment site deep within the GI tract. The current disclosure may solve one or more of these issues or other issues in the art.
- According to an example, a medical device may comprise an enclosure defining a cavity for containing agent, a lumen for receiving a pressurized gas, and a barrier positioned between the cavity and the lumen, the barrier including at least one opening for storing agent, wherein rotation of the barrier relative to the lumen establishes fluid communication between the at least one opening and the lumen for delivering agent from the at least one opening to the lumen. A bottom end of the cavity may include a wall adjacent to the barrier, wherein the wall includes a wall opening, wherein the wall opening is located on an area of the wall so that the wall opening is aligned with the at least one opening via rotation of the barrier. Alignment of the wall opening with the at least one opening may permit agent from the enclosure to enter the at least one opening. The enclosure may be rotatable relative to the barrier and/or the lumen. The barrier may be rotatable relative to the enclosure. The agent may remain in the at least one opening until fluid communication between the at least one opening and the lumen is established. The enclosure may feed the at least one opening with agent via gravity. The at least one opening for storing agent may feed the lumen with agent via gravity when fluid communication between the at least one opening and the lumen is established.
- In another example, the at least one opening for storing agent may be a plurality of openings arranged radially about the barrier. The plurality of openings may be symmetrically arranged. Each of the plurality of openings may be different in size. When fluid communication is established between one opening of the plurality of openings and the lumen, the other openings of the plurality of openings and the lumen are not in fluid communication.
- In another example, the medical device may further comprise an intermediary barrier, wherein the intermediary barrier is positioned between the barrier and the lumen, and wherein the intermediary barrier includes an intermediary opening positioned to be aligned with one of the plurality of openings via rotation of the barrier. The intermediary barrier may be rotatable relative to the barrier. The lumen may be a flexible catheter capable of traversing a tortuous body lumen, and further comprising a source of the pressurized gas.
- According to an example, a medical device may comprise a cartridge including a plurality of chambers, wherein each of the chambers stores a pre-filled amount of agent, a lumen for receiving a pressurized gas, a channel establishing fluid communication between a first end of the cartridge and the lumen for delivering agent from the cartridge to the lumen, and a plunger coupled to a second end of the cartridge so that the plunger is aligned with one chamber of the plurality of chambers, wherein the plunger advances longitudinally into the one chamber, thereby pushing the pre-filled amount of agent towards the channel, and wherein the cartridge is rotatable relative to the plunger to align the plunger with another of the plurality of chambers. The plunger may be coupled to the cartridge so that the plunger is spring-biased to a position outside of the one chamber and aligned with the one chamber. The medical device may further comprise a trigger including a lever coupled to a linkage via a first articulating joint and a linkage coupled to a plunger via a second articulating joint.
- According to an example, a method of administering an agent via a medical device may comprise positioning the medical device, including an enclosure, a barrier, and a lumen, so that a distal end of the lumen is adjacent to a targeted site, wherein the barrier is positioned between the enclosure and the lumen, the enclosure containing agent, and the barrier including at least one opening for storing the agent, providing a pressurized gas to the lumen, and rotating the barrier relative to the lumen so that fluid communication is established between the at least one opening and the lumen to deliver the agent from the at least one opening to the lumen. The method may further comprise rotating the barrier relative to the lumen so that the at least one opening and the lumen are not in fluid communication after a dose of the agent is delivered from the at least one opening to the lumen.
- The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the disclosed embodiments.
-
FIG. 1A is a side view of a portion of a shaft of an endoscope including a medical device, according to an embodiment. -
FIGS. 1B-C are cross-sectional views of the medical device ofFIG. 1A . -
FIG. 2A is a cross-sectional view of a medical device, according to another embodiment. -
FIG. 2B is a top view of the barrier ofFIG. 2A . -
FIG. 3A is a cross-sectional view of a medical device, according to another embodiment. -
FIG. 3B is a top perspective view of the barrier ofFIG. 3A over the intermediary barrier ofFIG. 3A . -
FIG. 4A is a side view of a medical device, according to another embodiment. -
FIG. 4B is a top view of the cartridge ofFIG. 4A . - Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term “distal” refers to a portion farthest away from a user when introducing a device into a subject (e.g., patient). By contrast, the term “proximal” refers to a portion closest to the user when placing the device into the subject.
- Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. In this disclosure, relative terms, such as, for example, “about,” “substantially,” “generally,” and “approximately” are used to indicate a possible variation of ±10% in a stated value or characteristic.
- The present disclosure may solve one or more of the limitations in the art. The scope of the disclosure, however, is defined by the attached claims and not the ability to solve a specific problem. The present disclosure is drawn to medical devices configured to administer doses of agents, e.g., therapeutic agents, among other aspects. The agent may be in any suitable form, including a powder form, which may be delivered to a stream of propellant/pressurized gas, e.g., CO2, nitrogen, air, etc. Said medical devices allow for the administration of agents in metered doses, which allows for a greater consistency in the quantity of the agent that reaches a target site.
- Referring to
FIG. 1A , a medical system 5, e.g., an endoscope, according to an embodiment is shown. Medical system 5 includes a flexible shaft 50 (e.g., a catheter) and ahandle 52 connected at a proximal end offlexible shaft 50.Handle 52, or some other device for actuating or controlling medical system 5 and any tool or devices associated with medical system 5, includes first and 42, 43, which control articulation ofsecond actuating devices flexible shaft 50, and/or an articulation joint at a distal end offlexible shaft 50, in multiple directions. 42, 43, may be, for example, rotatable knobs that rotate about their axes to push/pull actuating elements (not shown). The actuating elements, such as cables or wires suitable for medical procedures (e.g., medical grade plastic or metal), extend distally from a proximal end of medical system 5 and connect toDevices flexible shaft 50 to control movement thereof. Alternatively, or additionally, a user may operate actuating elements independently ofhandle 52. Distal ends of actuating elements may extend throughflexible shaft 50 and terminate at an actuating joint and/or a distal tip offlexible shaft 50. For example, one or more actuating elements may be connected to an articulation joint, and actuation of actuating elements may control the actuating joint or the distal end offlexible shaft 50 to move in multiple directions. - In addition, one or more electrical cables (not shown) may extend from the proximal end of endoscope 5 to the distal end of
flexible shaft 50 and may provide electrical controls to imaging, lighting, and/or other electrical devices at the distal end offlexible shaft 50, and may carry imaging signals from the distal end offlexible shaft 50 proximally to be processed and/or displayed on a display.Handle 52 may also include 54, 46 for introducing and/or removing tools, fluids, or other materials from the patient.ports Port 54 may be used to introduce tools.Port 46 may be connected to an umbilicus for introducing fluid, suction, and/or wiring for electronic components. For example, as shown inFIG. 1A ,port 54 receives atube 100, which extends from the proximal end to the distal end offlexible shaft 50, via a workingchannel 50 a ofshaft 50. - As shown in
FIG. 1A ,tube 100 of medical device 1 is attached to a pressurized gas source 56, e.g., CO2, which may be controlled by a user to turn on/off and to adjust a rate at which gas flows intotube 100. Source 56 may be a gas canister or tank, a source of gas supplied by a medical facility, or any other suitable source. Medical device 1 further includes anenclosure 10, and abarrier 11 positioned betweenenclosure 10 andtube 100.Enclosure 10 andbarrier 11 are coupled to a proximal portion oftube 100, distal of the connection betweentube 100 and source 56. -
FIGS. 1B and 1C illustrate an embodiment of medical device 1, l′ inFIG. 1A in further detail. As discussed above, medical device 1 includesenclosure 10 defining a cavity for containing anagent 1000, a tube (e.g., a catheter or a sheath) 100 defining alumen 100 a receiving pressurized gas, e.g., CO2, from a proximal end, andbarrier 11 positioned between the cavity ofenclosure 10 andlumen 100 a. The shape or size ofenclosure 10 is not particularly limited, and may be any suitable shape or size, including cylindrical. As indicated by the directional arrows inFIG. 1B ,barrier 11 is rotatable relative totube 100 andlumen 100 a, e.g., about a central axis ofbarrier 11. In other embodiments,barrier 11 may be rotatable relative to bothtube 100 andenclosure 10. In some other embodiments,enclosure 10 may be rotatable relative tobarrier 11 and/ortube 100. Rotation ofbarrier 11 may be by any suitable action, for example, by hand or by mechanical, electrical, or pneumatic action. -
Barrier 11 may be an annular, disk-like structure with openings and a passage therethrough. For example,barrier 11 includes afirst opening 12 a on the barrier surface (e.g., an upper surface) adjacent to the cavity ofenclosure 10, for receivingagent 1000 in apassage 14 that extends throughbarrier 11.Barrier 11 further includes asecond opening 12 b on the opposite barrier surface (e.g., a bottom surface) adjacent totube 100 andlumen 100 a, from whichagent 1000 may be dispensed intolumen 100 a. It is noted that the size and shape offirst opening 12 a andsecond opening 12 b are not particularly limited, and may be any suitable size or shape. First opening 12 a andsecond opening 12 b are located on opposite ends ofbarrier 11, but are connected viapassage 14 extending across the length and thickness ofbarrier 11.Tube 100 also includes anopening 101 which may or may not be aligned withsecond opening 12 b ofbarrier 11, depending on the rotational position ofbarrier 11 relative totube 100 andlumen 100 a. Thus, the rotation ofbarrier 11 relative totube 100 may establish fluid communication betweenopening 12 b andlumen 100 a for deliveringagent 1000 frompassage 14 to lumen 100 a.Enclosure 10 feeds opening 12 a withagent 1000 via gravity, andpassage 14storing agent 1000 feeds lumen 100 a withagent 1000 via gravity whensecond opening 12 b andlumen opening 101 are aligned. In other embodiments,agent 1000 may be delivered to opening 12 a and/orlumen 100 a via other suitable mechanisms.Barrier 11 may also be rotated so thatsecond opening 12 b andopening 101 oflumen 100 a are not aligned, thereby inhibiting the delivery ofagent 1000 frompassage 14 to lumen 100 a. In this instance,passage 14 receives and stores agent 10000, until fluid communication betweenopening 12 b ofpassage 14 andlumen 100 a is established. It is noted thatenclosure 10, in any rotational position ofbarrier 11, is not in fluid communication withlumen 100 a. Furthermore, in embodiments prior to any use,passage 14 may be empty an withoutagent 1000. - In some embodiments, a bottom end of the cavity of
enclosure 10 may include awall 105 adjacent tobarrier 11.Wall 105 may include anopening 105 a that may or may not be aligned with opening 12 a ofbarrier 11, depending on the rotational position ofbarrier 11 relative toenclosure 10. Thus, in such embodiments,barrier 11 and/orenclosure 10 may be rotated to align opening 105 a with opening 12 a ofbarrier 11 to deliveragent 1000 fromenclosure 10 topassage 14 through opening 12 a. This is illustrated inFIG. 1B , in which opening 105 a ofwall 105 and opening 12 a ofbarrier 11 are aligned, thereby feedingpassage 14 withagent 1000 fromenclosure 10.FIG. 1C showsbarrier 11 rotated by approximately 180° from its position inFIG. 1B relative toenclosure 10, and as a result, opening 105 a ofwall 105 and opening 12 a are not aligned, being on opposite ends from one another. It is understood that thebarrier 11 may be rotatable to any degree for alignment with opening 12 a. Thus, opening 12 a is sealed bywall 105, andagent 1000 is no longer fed into opening 12 a. It is noted that opening 105 a aligns with opening 12 a whensecond opening 12 b does not align with opening 101 oftube 100, and opening 105 a does not align with opening 12 a whensecond opening 12 b aligns with opening 101 oftube 100. Thus,passage 14 may receiveagent 1000, prior toagent 1000 being fed to lumen 100 a. This allows for medical device 1 to administer a metered dose, i.e., the amount ofagent 1000 stored inpassage 14, per each degree of rotation, e.g., 180°, ofbarrier 11 and/orenclosure 10. Furthermore, in some other embodiments, bothwall 105 andtube 100 may respectively include a plurality of openings. It is noted thatpassage 14 is capable of connecting openings ofwall 105 and oftube 100 that are 180° apart. However, this is not desired, and in such embodiments, none of the openings ofwall 105 are 180° apart from any of the openings oftube 100. As a result, there cannot be fluid communication betweenpassage 14 and said openings ofwall 105 andtube 100, at the same time. Instead, fluid communication betweenpassage 14 and the openings ofwall 105 andtube 100 is staggered, but not simultaneous. Such embodiments would allow for continuous rotation (both clockwise and counterclockwise) ofbarrier 11 relative toenclosure 10 to result inpassage 14receiving agent 1000 after a degree of rotation and subsequently dispensingagent 1000 after a further degree of rotation ofbarrier 11. - Referring to
FIGS. 1A-1C , an example of how medical device 1 may be used is further discussed below. A user may deliver a distal end oftube 100 of medical device 1 into the body of a subject, e.g., via a natural orifice (such as a mouth or anus) and through a tortuous natural body lumen of the subject, such as an esophagus, stomach, colon, etc.Tube 100 may be delivered in any suitable way, for example, through workingchannel 50 a of endoscope 5, by inserting a distal end oftube 100 intoport 54 of endoscope 5. A user may direct/position the distal end oftube 100 to an intended target site for administration ofagent 1000. A user may then fillenclosure 10 withagent 1000, if not filled already, and rotatebarrier 11 and/orenclosure 10 relative totube 100 andlumen 100 a so that opening 105 a aligns with opening 12 a, thereby feedingpassage 14 withagent 1000. As discussed above, when opening 105 a aligns with opening 12 a,second opening 12 b does not align with opening 101 oftube 100. Thus,agent 1000 is received and stored bypassage 14. A user may then rotatebarrier 11 to alignopening 12 b with opening 101 oftube 100, so that all ofagent 1000 stored inpassage 14 is fed frompassage 14 to lumen 100 a, thereby administering a metered dose ofagent 1000. A user may turn on the pressurized gas source at any time prior to the alignment ofopening 12 b withopening 101 and supply pressurized gas until the metered dose ofagent 1000 reaches the target tissue site. Alternatively, a user may start supply of pressurized gas after the supply ofagent 1000 to lumen 100 a. - In
FIG. 2A , another embodiment of medical device 1′ is shown. Like the embodiment discussed above, medical device 1′ includes anenclosure 10′ defining a cavity for containing anagent 1000, a tube (e.g., a catheter or a sheath) 100 defining alumen 100 a receiving pressurized gas, e.g., CO2, from a proximal end, and abarrier 21 positioned between the cavity ofenclosure 10 andlumen 100 a. The shape or size ofenclosure 10′ is also not particularly limited, and may be any suitable shape or size. As indicated by the directional arrows inFIG. 2A ,barrier 21 is also rotatable relative totube 100 andlumen 100 a. In other embodiments,barrier 21 may be rotatable relative to bothtube 100 andenclosure 10′. In some other embodiments,enclosure 10′ may be rotatable relative tobarrier 21 and/ortube 100. Rotation ofbarrier 21 andenclosure 10′ may also be actuated by any suitable action. -
Barrier 21, as shown in bothFIGS. 2A and 2B , includes a plurality of openings, i.e., six openings 22 a-22 f, of equal or approximately equal size, i.e., width or diameter, symmetrically arranged radially about a central axis of rotation ofbarrier 21. It is noted that the number of openings, the size of openings, the shape of openings, and the arrangement of openings onbarrier 21 is not particularly limited, and may be any suitable configuration. For example, in other embodiments,barrier 21 may have four circular openings, each of which has varying diameters from one another. Each of openings 22 a-22 f extends through the thickness ofbarrier 21, and is configured to receive and store a pre-determined or selected amount ofagent 1000, depending on the size of the openings. Thus,agent 1000 fromenclosure 10 feeds into openings 22 a-22 f, via gravity in some embodiments, until said openings are filled. Note thatFIG. 2A shows half ofbarrier 21 in perspective to show the position of openings 21 a, 21 b, 21 c, and 21 d. - By rotation of
barrier 21 relative totube 100 andlumen 100 a, one of openings 22 a-22 f may align withopening 101, thereby establishing fluid communication between the one opening andlumen 100 a for deliveringagent 1000 from the one opening to lumen 100 a via gravity. In some embodiments,enclosure 10′ may further include aseal 205, which is positioned adjacently abovebarrier 21, above where one of openings 22 a-22 f may be located, and directly above opening 101 oftube 100. Thus, as one opening of openings 22 a-22 f aligns with opening 101 via rotation ofbarrier 21, an excess amount ofagent 1000 above the one opening is shaved off byseal 205 and the one opening is sealed from receivingfurther agent 1000 fromenclosure 10′ when that opening aligns with opening 101 oftube 100. This allows for medical device 1′ to administer a metered dose, i.e., the amount ofagent 1000 stored in openings 22 a-22 f, per each degree of rotation, e.g., 60°, ofbarrier 21 and/orenclosure 10′. It is noted that as a result of such configuration, when fluid communication is established between one of openings 22 a-22 f and lumen 100 a, no fluid communication is established between the other remaining openings and lumen 100 a, as the bottom of the remaining openings is sealed bytube 100. - As shown in
FIG. 2B , which shows a top view ofbarrier 21,barrier 21 may also be rotated so that none of openings 22 a-22 f are aligned with opening 101 oftube 100, thereby inhibiting the delivery ofagent 1000 from any of openings 22 a-22 f to lumen 100 a. In this instance, an amount ofagent 1000 is stored in openings 22 a-22 f until fluid communication between the openings and lumen 100 a is established. - Referring to
FIGS. 2A-2B , an example of how medical device 1′ may be used is further discussed below. Similar to medical device 1, medical device 1′ may be delivered into the body of a subject, and directed to an intended target site foragent 1000 administration in the same manner. A user may then fillenclosure 10′ withagent 1000, if not filled already, which will fill openings 22 a-22 f withagent 1000. The user then may rotatebarrier 21 relative totube 100 andlumen 100 a so that one of openings 22 a-22 f aligns withopening 101. Such alignment results inseal 205 shaving off an excess amount ofagent 1000 above the one opening, sealing the one opening from being fed any more ofagent 1000 fromenclosure 10′, andfeeding lumen 100 a withagent 1000 stored in the one opening. As discussed above, when the one opening aligns with opening 101 oftube 100, the remaining openings 22 a-22 f do not align with opening 101 oftube 100. Thus,agent 1000 is stored within the remaining openings 22 a-22 f, until each of the remaining openings is aligned with opening 101 via rotation ofbarrier 21, in turn. A user may turn on the pressurized gas source at any time prior to or during the alignment of one of the openings 22 a-22 f withopening 101, as in the embodiment described in connection withFIGS. 1B-1C . - In
FIG. 3A , another embodiment of medical device 1′″ is shown. Medical device 1′″ is similar to medical device 1′, and differences between the two devices will be highlighted. Device 1′″ may include any of the features of device 1′ and operate in the same or substantially the same way. Medical device 1′″ includes anenclosure 10′″, abarrier 41, andlumen 100. Moreover,enclosure 10′″ further includes aseal 205, which is positioned adjacently abovebarrier 41, above where one ofopenings 42 a-42 c may be located, and directly above opening 101 oftube 100. However, unlike medical device 1′,lumen 100 a of medical device 1′″ receives pressurized gas from asecond lumen 102, which is connected totube 100 at a point that is proximal toopening 101. Alternatively, medical device 1′″ may receive pressurized gas from a proximal end oflumen 100 a, and may be withoutsecond lumen 102. Medical device 1′″ further includes, in at least some embodiments, anintermediary barrier 15 including anopening 16, positioned betweenbarrier 41 andtube 100. As indicated by the directional arrows inFIG. 3A ,barrier 41 is rotatable relative tointermediary barrier 15,tube 100, and lumen 100 a. In other embodiments,enclosure 10′″ may also be rotatable relative tobarrier 41,intermediary barrier 15,tube 100, and lumen 100 a. Rotation ofenclosure 10′″ andbarrier 41 may be actuated by any suitable action. -
Barrier 41, as shown in bothFIGS. 3A and 3B , includes three openings, i.e., 42 a-42 c, of different sizes, i.e., widths or diameter, arranged radially about a central axis of rotation ofbarrier 41, like barrier 21 (referring toFIG. 2B ). Afirst opening 42 a has the smallest width of the three openings, a second opening 42 c has the largest width of the three openings, and athird opening 42 b has a width in between that offirst opening 42 a and that of second opening 42 c. Thus, each ofopenings 42 a-42 c receives and stores different amounts or doses ofagent 1000. - To help a user differentiate between the different sizes of
openings 42 a-42 c,enclosure 10′″ and/orbarrier 41 may further include markings on their outer surfaces that indicate the locations ofopenings 42 a-42 c relative to one another, and to 16 and 101. Thus, a user may rotateopenings barrier 41 and/orenclosure 10′″, relative tointermediary barrier 15,tube 100, and lumen 100 a, to select one ofopenings 42 a-42 c based on a desired amount or dose ofagent 1000. -
Intermediary barrier 15, as shown in bothFIGS. 3A and 3B , includesopening 16.Opening 16 may be aligned withlumen opening 101, and alsoopenings 42 a-42 c, depending on the rotational position ofbarrier 41 relative tointermediary barrier 15. As shown inFIG. 3B , opening 16 is at least the same width as the largest opening ofbarrier 41, i.e., second opening 42 c. - Any one of
openings 42 a-42 c may be aligned withintermediary opening 16 andlumen opening 101 via rotation ofbarrier 21. Such alignment establishes fluid communication between one ofopenings 42 a-42 c andlumen 100 a for deliveringagent 1000 from one ofopenings 42 a-42 c to lumen 100 a via gravity. Similar to that of medical device 1′, as one opening ofopenings 42 a-42 c aligns with opening 16 ofintermediary barrier 15 andopening 101 via rotation ofbarrier 41, an excess amount ofagent 1000 above the one opening is shaved off byseal 205 and the one opening is sealed from further receivingagent 1000 fromenclosure 10″. This allows for medical device 1′″ to administer a metered dose, the amount ofagent 1000 stored inopenings 42 a-42 c, per each degree of rotation, e.g., 120°, ofbarrier 41. As a result of such configuration, when fluid communication is established between one ofopenings 42 a-42 c andlumen 100 a, no fluid communication is established between the other remainingopenings 42 a-42 c andlumen 100 a. -
Barrier 41 may also be rotated so that none ofopenings 42 a-42 c is aligned withintermediary opening 16 andlumen opening 101, thereby inhibiting the delivery ofagent 1000 fromenclosure 10′″ to lumen 100 a. In this instance, varying amounts ofagent 1000 are stored inopenings 42 a-42 c until fluid communication betweenopenings 42 a-42 c andlumen 100 a is established. - It is further noted in some embodiments,
intermediary barrier 15 may also be rotatable relative toenclosure 10′″,barrier 41,tube 100, and lumen 100 a, so that opening 16 does not align with any of the openings ofbarrier 41, and/oropening 101 as well. This is applicable in embodiments having barriers with multiple openings. By being able to misalign opening 16 from opening 101, a user may select another 42 a, 42 b, 42 c, etc., via rotation ofopening barrier 41, that is not adjacent to the currently aligned opening, without having to inadvertently dispenseagent 1000 stored in openings adjacent to the currently aligned opening, via the necessary degree of rotation to select other non-adjacent openings. - Referring to
FIGS. 3A-3B , an example of how medical device 1′″ may be used is further discussed below. Similar to medical devices 1 and 1′, medical device 1′″ may be delivered into the body of a subject, and directed to an intended target site foragent 1000 administration in the same manner. A user may then fillenclosure 10′ withagent 1000, if not filled already, and rotatebarrier 41 relative tointermediary barrier 15,tube 100, and lumen 100 a, so that one ofopenings 42 a-42 c aligns with 16 and 101. Such alignment results inopenings seal 205 shaving off an excess amount ofagent 1000 above the one opening, sealing the one opening from being fed any more ofagent 1000 fromenclosure 10′″, andfeeding lumen 100 a withagent 1000 stored in the one opening. As discussed above, when the one opening aligns with opening 16 ofintermediary barrier 15 andopening 101 oftube 100, the remainingopenings 42 a-42 c do not align with 16 and 101. Thus,openings agent 1000 is stored within the remainingopenings 42 a-42 c, until each of the remaining openings is aligned with 16 and 101 via rotation ofopenings barrier 41. A user may turn on the pressurized gas source at any time prior to or during the alignment of one of theopenings 42 a-42 c with 16 and 101, as in previously described embodiments.openings - Referring to
FIG. 4A , another embodiment of medical device 1″ is shown. Medical device 1″ includes atrigger 18, a rotatingcartridge 31 including a plurality of chambers, alumen 100 receiving pressurized gas from a proximal end, and achannel 14 establishing fluid communication between a distal end ofcartridge 31 andlumen 100 for deliveringagent 1000 fromcartridge 31 tolumen 100. As shown inFIG. 4B ,cartridge 31 includes a plurality of symmetrically-arranged chambers, i.e., six chambers 32 a-32 f, of equal or substantially equal size, each of which stores a pre-filled amount ofagent 1000. -
Trigger 18 includes alever 18 a coupled to alinkage 18 c via an articulating joint 18 b, andlinkage 18 c coupled to aplunger 18 e via another articulating joint 18 d. A distal portion ofplunger 18 e is housed within a proximal portion ofcartridge 31, and is coupled tocartridge 31 in any suitable manner so that the distal end ofplunger 18 e faces one of chambers 32 a-32 f with which plunger 18 e is aligned. Aspring 19 coils around a distal portion ofplunger 18 e outside ofcartridge 31 up until a stop 17 fixated onplunger 18 e, thereby spring-biasingplunger 18 e in its aforementioned position of facing one of chambers 32 a-32 f.Spring 19 is not particularly limited and may be any suitable spring. Likewise, stop 17 may be of any suitable material, such as rubber. -
Trigger 18 is configured so that whenlever 18 a is pulled proximally,linkage 18 c likewise pivots proximally relative toplunger 18 e via articulating joint 18 d. Such movements oflever 18 a andlinkage 18 c result inplunger 18 e longitudinally advancing towardscartridge 31 and into one of chambers 32 a-32 f, thereby propelling the pre-filled amount ofagent 1000 towards and throughchannel 14, which extends downward totube 100, thereby feedingagent 1000 totube 100 via gravity. The longitudinal advancement ofplunger 18 e may be actuated by any suitable mechanisms, including, but not limited to, mechanical, electrical, or pneumatic mechanisms.Plunger 18 e advances withincartridge 31 and one of chambers 32 a-32 f up untilspring 19 is fully compressed, thereby inhibiting any further advancement ofplunger 18 e towardscartridge 31. Oncelever 18 is released, spring-biasedplunger 18 e automatically reverts back to its initial position of being outside of and facing one of chambers 32 a-32 f. -
Cartridge 31 is rotatable relative to plunger 18 e so that any one of chambers 32 a-32 f is aligned withplunger 18 e. In some embodiments,cartridge 31 may be configured to rotate or revolve automatically, after one of chambers 32 a-32 f is emptied byplunger 18 e, so that an adjacent chamber 32 a-32 f storing a pre-filled amount ofagent 1000 is aligned withplunger 18 e. - It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the disclosure. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
Claims (21)
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| DE102018211297A1 (en) | 2018-07-09 | 2020-01-09 | Kardion Gmbh | Cardiac support system and method for monitoring the integrity of a support structure of a cardiac support system |
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